August 23, 2003

STAAR Surgical Company Claims Implantable Contact Lenses Safer than Lasik

Ophthalmics device company reports 99.4% patient satisfaction

STAAR Surgical Company (STAA) reported that the July/August 2003 edition of the Journal of Refractive Surgery has published the findings of a study comparing the retinal image quality and postoperative aberrations of patients of laser in situ keratomileusis (LASIK) with patients that were implanted with STAAR's ICL.

The article entitled "Image Quality in Myopic Eyes Corrected with Laser in situ Keratomileusis and Phakic Intraocular Lens" authored by Edwin J. Sarver, PhD, Donald R. Sanders, MD, PhD, and John A. Vukich, MD, concluded that eyes that were treated with the LASIK procedure had on average, up to three times more aberrations than eyes that were implanted with the ICL.

These aberrations can cause images to appear hazy or blurred and slightly out of focus. The prevalence of these aberrations tends to be higher in procedures involving the cornea, such as LASIK, as opposed to those that preserve the cornea, such as ICL surgery. Once induced, these aberrations cannot easily be corrected. They would not necessarily affect the ability of the patient to read the lines on an eye chart but would affect the clarity of that image.

In the article, the postoperative results of 19 eyes on which LASIK surgery had been performed and 20 eyes that had been implanted with the ICL by the same surgeon during the same time period were compared. The average level of myopia for the LASIK patients was minus 6.50 diopters and ranged from minus 4.00 diopters to minus 9.00 diopters while the ICL patients had a meaningfully higher level of myopia at an average of minus 9.80 diopters and ranged from minus 4.25 to minus 20.00 diopters.

Sarver, Sanders, and Vukich reported that the level of all higher order aberrations was three times greater in LASIK patients than in ICL patients. By comparing these results the investigators were able to create a mathematical model that simulated a visual image that illustrated what the patients were actually seeing after surgery.

The comparison clearly demonstrates a sharper and clearer image in the ICL patients. The study also referenced other studies in which LASIK was performed in one eye and an ICL was implanted in the other where most patients preferred the vision in the ICL eye. The doctors believe that the better image quality achieved through ICL implantation is the reason why patients that had both procedures performed preferred the ICL.

"Our positive 3-year follow-up data on the ICL showed a 99.4% patient satisfaction rate," said David Bailey, president and CEO of STAAR Surgical. "We believe that one of the reasons why the satisfaction rate was so high is because the quality of vision that ICL patients achieve postoperatively is superior to other available technologies. This study demonstrates that ICL patients will have less image distortion than patients undergoing LASIK. We believe that the results of this study combined with the 3-year data presented at the ASCRS and the study that concluded that the ICL was safer and more effective than LASIK illustrate why the ICL will become a prominent choice for vision correction.

"Based on the satisfaction rate detailed in our 3-year study, it's apparent that patients are evaluating not only the level of correction that a procedure offers, but also the image quality. After the probable outcomes are reviewed, we feel confident that a number of doctors and patients will choose the ICL because it offers superior image quality."

The STAAR ICL is a phakic refractive lens that is currently under FDA review for marketing in the U.S.. The current submission is for the correction of myopia, or nearsightedness, in the range of -3.0D to -20.0D. The company is presently enrolling candidates in the clinical trial for the hyperopic ICL as well as the Toric ICL, which reduces myopia combined with astigmatism.

The STAAR ICL premarket approval application has been accepted for substantive review by the U.S. Food and Drug Administration and has been granted an expedited review status. The official filing date for the ICL PMA was May 8, 2003.STAAR's ICL has received CE Marking, is approved for sale in 37 countries, and has been implanted in more than 30,000 eyes worldwide. If granted approval by the FDA, STAAR will be allowed to market the ICL in the United States for the reduction of nearsightedness.

This article was prepared by Drug Week editors from staff and other reports.

Posted by Admin at August 23, 2003 10:40 PM